RADIATION-BASED STERILIZATION AND ITS EFFECTS ON POLYMER MATERIALS.

M.V. VOGT; M.N.CIAVARO; A.J. PACHADO; M.F. DEL GROSSO

Jornada; IAEA; 2021

Even though photons (gamma source and X ray), or particles (electrons) can be used for sterilization of medical devices, throughout the last decades 60Co, has been used as a source of gamma ionizing radiation for a wide variety of applications, and it has become one of the most used methods for the sterilization of medical devices.In Argentina, radiation sterilization technology is based on 60Co sources but there is a growing interest in electron beams and X-rays not only just for sterilization purposes but also for irradiation of packaging and food, among others. In order to encourage the use of electron accelerators as a sterilizing method, it is important to know the effects that they generate on the materials of medical devices. In this coordinated research project, some polymers commonly used in medical devices and health care products such as polypropylene (PP), acrylonitrile butadiene styrene (ABS) and polylactic acid (PLA), will be analyzed. These polymers will be irradiated under different conditions (dose, dose rate) with gamma rays and electron beams, under vacuum and air environment. The mechanical properties will be analyzed through mechanical test (tensile, compressive, flexural), thermal and chemical properties (differential scanning calorimetry: DSC and fourier transform infrared spectroscopy: FTIR, yellowness index, biocompatibility assay and its accelerated aging will also be analyzed. Finally, at least one medical device or health care product made up of one of the selected polymers will be studied. The minimum sterilization dose and functionality of a selected product will be analyzed and Its primary packaging will be evaluated by airtightness tests to study if it can preserve the sterility of the product.